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Designing a CAPA System that Meets and Exceeds Regulatory Requirements - Webinar By GlobalCompliancePanel

 
  April 11, 2011  
     
 


GlobalCompliancePanel, Online Training Webinar
2011-05-17


Overview: CAPA is the most audited Quality subsystem in any Quality system. Most of the warning letters written by the FDA in 2010 were CAPA relate. Avoiding FDA CAPA findings starts with the design of a robust CAPA SYSTEM.

The webinar covers "Off-label statute" and the FDA's nonbinding off-label guidance as relates to re-prints, performance claims, and Promotion. Emphasis is placed on ethical, moral, and legal expectations from the FDA.

Why Should You Attend: The webinar is designed for mid-level Quality Engineers and Quality Engineers who design and manage the Quality system.

What you will learn:
  • The CAPA definition
  • the CAPA LIFE cycle
  • Tools for each CAPA cycle
  • CAPA requirements 
  • Tools for Preventive Action
  • Common FDA CAPA findings and how to avoid them
Areas Covered In the Session:
  • Off-label statute
  • Label claims
  • Allowable reprints
  • Promotional compliance
  • FDCA: The law
Who will benefit:
  • Sales executives in Medical Device
  • Regulatory Affairs personnel
  • Executives
  • Corporate counsel
  • Quality personnel
  • Directors
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: Mr. Muchemu has over fifteen years experience in Medical Device, Pharmaceutical, Biomedical and Tissue industries as CAPA Training Instructor, Process validation Instructor, Change control Instructor, and CGMP consultant. He has held major positions at Abbott labs, Genentech, Boston Scientific, and Johnson and Johnson. He holds degrees in Biology, Chemical Engineering, and is currently working an MBA with a concentration in Public Health. He is an established author of several GMP books.
 
Deadline for Abstracts: 2011-05-17
 
Registration: Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
E-mail: webinars@GlobalCompliancePanel.com
 
   
 
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